Diabetes is a chronic disease that has no cure. It affects 16 million people in the U.S. and more than 125 million people worldwide. Diabetes is the fourth-leading cause of death by disease in the United States. In 1997, more than 178,000 people died from the disease and its relates complications.
Diabetes mellitus is characterized by an impaired ability to metabolize carbohydrates, increased glucose in the blood, and excretion of glucose in the urine. This defect involves interference with insulin in its role of facilitating uptake of glucose by cells, to give energy as ATP.
In people with diabetes, the pancreas produces insufficient or no insulin, the hormone which is responsible for the absorption of glucose into cells for energy needs. As a result, the level of glucose in the blood becomes abnormally high, causing excessive urination and constant thirst and hunger. The body's inability to store or use glucose causes weight loss and fatigue. Diabetes mellitus also results in disordered lipid metabolism and accelerated degeneration of small blood vessels.
There are two main types of diabetes mellitus. Type I which is the more severe form, usually first appears in people under the age of 35 and most commonly in people between the ages of 10 and 16. It develops rapidly. The insulin-secreting cells in the pancreas are destroyed, probably as a result of an immune response after a virus infection, and insulin production ceases almost completely. Without regular injections of insulin the sufferer lapses into a coma and dies. Type I diabetes results from the pathological error due to the inability of beta cells of the islets of Langerhans to secrete insulin. It may be due to a genetic disposition or a viral infection, wherein the beta cells are suppressed and are unable to secrete insulin. Individuals suffering from Type I diabetes are totally insulin dependent and is normally manifested by age 25.
The most prevalent type of diabetes, Type II diabetes, is usually of gradual onset and occurs mainly in people over 40. In many cases it is discovered only during a routine medical examination. Patients with Type II diabetes have this condition due to pathological error of malabsorption of glucose or impaired utilization of peripheral insulin or due to the result of abnormal erythrocyte receptors (partly genetic), accounts to absorption/utilization of glucose/insulin. Not enough insulin is produced to meet the body's needs, especially when the person is overweight. Often the body is resistant to the effects of insulin as the receptors are deactivated. In most cases, insulin-replacement injections are not initially required. The combination of dietary measures, weight reduction and oral medication can keep the condition under control for a period of time, but most people with Type II diabetes ultimately require insulin injections.
One of the complications of Type I and Type II diabetes is production of abnormal glycated compounds. Glycation and glycoxidation, a sequential process, is often encountered in uncontrolled Type I and Type II diabetics. This involves the surface protein of LDL, and its component apolipoprotein B, which contributes to atherogenicity. Glycated and glycoxidated products are chemotactic to monocytes. The monocytes in the vascular cells infiltrate to macrophage, and form foam cells in the vascular collagen, facilitating adhesion of lipoproteins, suppressing immune complexes and resulting in atherosclerotic plaques. Lysine-fructose in blood is an indicator of the extent of glycation before and after treatment. Carbomethoxy lysine in serum is an indicator of the extent of glycoxidation--before and after treatment.
In patients with Type II diabetes, there is an imbalance between oxidants and antioxidants leading to endothelial dysfunction, which can predispose the patients to atherosclerosis and target organ damage. The levels of lipid peroxidation are high with simultaneous decrease in those antioxidants such as superoxide dismutase, Vitamin E, glutathione peroxidase, methionine reductase and nitric oxide.
The long-term complications of the disease usually are a decreased life expectancy, neuropathy, and an increased rate of blindness (by 25 times), an increased rate of kidney disease (by 17 times) and an increased rate of heart disease (2 times) in comparison to nondiabetics. Type I and Type II diabetics are always associated with hypercholesterolemia and hyperlipidemia.
As stated above, diabetes may be controlled with insulin and in some cases through careful diet. However, the blood sugar levels will still fluctuate (sometimes dramatically), in patients undergoing insulin or diet therapy. Furthermore, in cases where the diabetes is severe, patients find it necessary to constantly monitor their glucose levels to prevent associated illnesses. Diabetic patients are forced to inject insulin which ultimately leads to bruising in certain areas. Furthermore, additional medical complications often arise from diabetes such as arteriosclerosis, hyperlipidemia, retinal damage, neurological damage, fatigue and weakness.
Therefore, there is a need for a safe and effective treatment for diabetes with minimal side effects and without the invasive procedures, such as injections. In addition, there remains a need for a treatment which addresses other medical ailments which often accompany diabetes, to insure that patients remain in the best health possible. The present invention fulfills these and other needs.